TOMMY Trial (a comparison of tomosynthesis with digital mammography in the UK NHS breast screening programme) setting up a multicentre imaging trial
© Gilbert et al. 2011
Published: 4 November 2011
Digital breast tomosynthesis (DBT) has the potential to improve the accuracy of standard digital mammography (DM) . The TOMMY Trial is a multicentre, multireader, retrospective matched comparison of the diagnostic performance of DBT and DM.
Women (47 to 73 years old) recalled for further assessment after routine breast screening and women <50 years with a family history of breast cancer, attending annual mammographic screening. Intervention Women who consent to participate in the trial undergo standard two-view DM and DBT imaging of both breasts. Images are acquired in a single examination under the same degree of breast compression on a commercially available (Hologic) digital mammography system.
The primary outcome measure is the relative sensitivity and specificity of DM and DBT in the detection of early-stage cancers and subtle lesions, particularly in women with dense breasts. This will be evaluated in a retrospective reading study where readers at each centre conduct blinded independent reviews of anonymised DM, or DBT, or DM and DBT images of cases from other centres.
The trial set-up has involved lengthy and complex legal negotiation with collaborating sites, the equipment manufacturer and the grant-awarding body. Designated readers from each centre have completed tomosynthesis training and recruitment has commenced.
It should be noted that the negotiation of contracts and commercial agreements adds a considerable time burden to the set-up phase of multicentre trials.
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